Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

The Best Treatment Strategy: Surgical vs Pharmacological to Close the Ductus Arteriosus Persistent in Preterm Infants

16 november 2015 bijgewerkt door: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

The Best Treatment Strategy: Surgical Versus Pharmacological, to Close the Ductus Arteriosus Persistent in Preterm Infants. A Randomized Controlled Trial

The decision to treat patent ductus arteriosus in preterm infants, varies from a conservative, medical or immediate surgical treatment; although, at present, there is some controversy about this decision. This study aims to determine the efficacy and safety of surgical versus pharmacological treatment of patent ductus arteriosus in preterm infants.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The ductus arteriosus varies in length, diameter and morphology. The duct closure occurs in two stages: the first one or functional closure; the second or anatomical closure. This condition is associated with other heart diseases, which modify the natural history and require individualized treatment. Treatment varies from conservative, pharmacological or surgical treatment, and there are many controversies regarding the treatment decision. And aims of the closure, is to decrease the likelihood of irreversible pulmonary vascular disease, reduce associated morbidity and mortality. The role of prostaglandin E2 is the permeability of the conduit, by which is indicated the use of cyclooxygenase inhibitors for closure (indomethacin and ibuprofen). In various research studies many factors associated with failure of pharmacological treatment (gestational age, antenatal indomethacin less than 48 hours before delivery, use of high frequency ventilation) are reported, therefore, there is an alternative treatment which is surgical closure. In the pharmacological treatment of ductus arteriosus persistent it should be individualized according to gestational age, respiratory condition and size of the newborn. With early drug treatment can achieve closure of patent ductus arteriosus in up to 90% of cases, while the late treatment between 50-65%. However, it is reported that after treatment with indomethacin, reopening occurs, two doses are recommended more after the first, in addition to its side effects, contraindications and complications. As well, ibuprofen contraindications. So the closure of the ductus arteriosus persistent may be performed by hemodynamics and surgical closure (standard left thoracotomy or thoracoscopic technique). There are specific indications for surgical treatment (no response to two cycles of medical treatment in newborns with less than 1000 gr weight in which I fail one indomethacin, absolute contraindications to it, with significant hemodynamic repercussions. With surgical treatment before the third week of life minimizing morbidity. it is reported by many authors that complications are rare and mortality is associated with other complications of prematurity. So Surgical treatment is considered as an alternative because of its low incidence of complications, mortality and lower cost, plus a total occlusion between 94-100% Because of this, the treatment of patent ductus arteriosus in preterm infants, ranging from conservative treatment, medical or surgical, and currently there is much controversy in the treatment decision.

This study aims to determine the efficacy and safety of surgical versus pharmacological treatment for the permanent closure of the patent ductus arteriosus in preterm infants.

Methods: Is open label randomized controlled the clinical trial with: 1) experimental group assigned to surgical treatment; 2) control group assigned to pharmacological treatment, for closure of patent ductus arteriosus.

Studietype

Ingrijpend

Inschrijving (Verwacht)

40

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Mexico
      • Distrito Federal, Mexico, 04477
        • Werving
        • Hospital General Naval de Alta Especialidad
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 dag tot 4 weken (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Preterm infants
  • Preterm infants hospitalized in the Neonatal Intensive Care Unit with a diagnosis of patent ductus arteriosus

Exclusion Criteria:

  • Preterm infants with supportive treatment and / or drug prior to patent ductus arteriosus in another medical unit
  • Preterm infants diagnosed with heart disease associated complex.
  • Preterm infants with associated disease (not hemodynamic or cardiovascular) and its impact on his state of health prior to drug treatment and / or surgery
  • Preterm infants with contraindications to pharmacological and / or surgery treatment
  • Newborns diagnosed with patent ductus arteriosus but with incomplete medical records

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Surgical treatment
Implement surgical treatment for closure of patent ductus arteriosus
Procedure: Surgical treatment
Standard left thoracotomy
Andere namen:
  • Chirurgie
Actieve vergelijker: Control group

- Indomethacin: Administer 1 full cycle (3 doses) of indomethacin (1 dose every 12 hours) for 2 days Dose 0.1 - 0.25 mg / kg

- Ibuprofen: Administer 1 full cycle (3 doses) of ibuprofen (1 dose every 24 hours) for 2 days Dose 05 - 10 mg / kg

- Acetaminophen: Administer 1 full cycle (12 doses) of acetaminophen (1 dose every 6 hours) for 3 days Dose 15 mg / kg
Geneesmiddel: Control group

- Indomethacin:

Administer 1 full cycle (3 doses) / (1 dose every 12 hours) in the first fourteen days of life:

Preterm infants less than 48 hours of life: first dose 0.2 mg/kg, second dose 0.1 mg/kg and third dose 0.1 mg/kg Preterm infants more than 48 hours of life: first dose 0.2 mg/kg, second dose 0.2 mg/kg and third dose 0.2 mg/kg And preterm infants more than 7 days of life: first dose 0.2 mg/kg, second dose 0.25 mg/kg and third dose 0.25 mg/kg - Ibuprofen:

Administer 1 full cycle (3 doses) / (1 dose every 24 hours) in the first fourteen days of life of preterm infants:

First dose 10 mg/kg Second dose 05 mg/kg Third dose 05 mg/kg

- Acetaminophen

Administer 1 full cycle, in the first fourteen days of life in preterm infants:

Acetaminophen 15 mg/kg every 6 hours for 3 days

Andere namen:
  • Farmacologisch

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Success rate of closure patent ductus arteriosus
Tijdsspanne: 10 days after treatment
Tracking each patient for 10 days after treatment (surgical / pharmacological) to verify success rate of closure of patent ductus arteriosus (Failure of ductal closure ) (%)
10 days after treatment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time from diagnosis to resolution of patent ductus arteriosus
Tijdsspanne: 1 month
To compare the time from diagnosis to resolution of patent ductus arteriosus (days)
1 month
Time from start of treatment until resolution
Tijdsspanne: 10 days after treatment
To compare the time from start of treatment until resolution of patent ductus arteriosus (days)
10 days after treatment
Time limitation of family contact
Tijdsspanne: 1 month
To compare the time limitation of family contact from diagnosis to hospital discharge of newborns of patent ductus arteriosus (days)
1 month
Adverse effects and complications of treatment
Tijdsspanne: 10 days
Describe the type of adverse effects and / or complications (Chronic lung disease , Intraventricular haemorrhage, Creatinine level > 1.8 mg/dl, Pneumothorax , Sepsis, Necrotising enterocolitis, Retinopathy of prematurity, Other bleeding) and the frequency of the two study groups (yes / no)
10 days
Death before discharge
Tijdsspanne: 1 month
To compare related mortality among surgical and pharmacological treatment (%)
1 month
Time of mechanical ventilatory support, parenteral nutrition, fasting, supplementary O2
Tijdsspanne: 1 month
To compare the duration of mechanical ventilatory support, parenteral nutrition, fasting, supplementary O2 (days).
1 month
Anatomy of the ductus arteriosus persistent
Tijdsspanne: 1 month
Describe the size of the ductus arteriosus (mm)
1 month
Gestational age at birth
Tijdsspanne: At birth
Describe the gestational age of neonates (weeks)
At birth
Apgar
Tijdsspanne: At birth
Describe the Apgar score of newborns (3-9)
At birth
Blood flow
Tijdsspanne: 1 month
Describe the direction of blood flow of the ductus arteriosus (left-right, left-right, two-way)
1 month
Gradient of the ductus arteriosus
Tijdsspanne: 1 month
Describe the gradient of the ductus arteriosus (mmHg).
1 month

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Onderzoekers

  • Hoofdonderzoeker: Esaú Luis Nieto, Pediatrician, Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2015

Primaire voltooiing (Verwacht)

1 april 2016

Studie voltooiing (Verwacht)

1 oktober 2017

Studieregistratiedata

Eerst ingediend

8 november 2015

Eerst ingediend dat voldeed aan de QC-criteria

9 november 2015

Eerst geplaatst (Schatting)

11 november 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

17 november 2015

Laatste update ingediend die voldeed aan QC-criteria

16 november 2015

Laatst geverifieerd

1 november 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HGNAE-07

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Aanhoudende Ductus Arteriosus

Klinische onderzoeken op Surgical treatment

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in France

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren